I want to follow-up on the blog I posted earlier today about the Erbitux announcement.
No, I haven’t heard from the company, so there is no further information to report as to the effectiveness of Erbitux in the “first line” treatment of patients with advanced colorectal cancer.
What is interesting is that I am not the only one having some difficulty today about how companies report the information from their clinical trials.
This afternoon the New England Journal of Medicine published two studies on new drugs for the treatment of advanced renal cell carcinoma (kidney cancer).
These reports reviewed two clinical trials for two different targeted therapies, sorafenib and sunitinib.
In both cases, these drugs delayed the time it took for the kidney cancer to progress.
The sorafenib studies had been completed in early 2005, and in December 2005 the drug was approved by the FDA for the treatment of advanced kidney cancer.
The sunitinib data was presented at the ASCO annual meeting in June 2006.
One of these papers almost did not get published in the New England Journal, which is considered one of the premier—if not the premier—medical journals because the drug company which sponsored the study did not comply with open disclosure requirements.
In an editorial written by the editors of the Journal, they point out that it wasn’t the scientific quality of the paper on sunitinib that led to its initial rejection by the Journal.
It was the fact that the trial had not been registered for public disclosure and review.
That is a no-no among certain medical journals that have agreed to follow standard procedures, including requiring clinical trials to be publicly registered in advance, if the results of those trials were eventually to be considered for publication in those particular journals.
The editors noted that the drug company which had sponsored the trial stated the following on their trial registration form:
“Primary (Secondary) outcome information was omitted due to [its] commercial sensitivity and will be revealed at a later date.”
Fortunately for the study authors, another investigator had in fact registered all of the appropriate information in a public clinical trials database, so the paper was accepted for publication after all.
The editors conclude, “Before you enroll a patient in a study, be sure that there is a full and appropriate registration of the trial in a public database approved by the ICMJE…It could salvage a study report that otherwise would not be published.”
Why is this registration so important?
Until recently, there was no required public record of clinical trials. And, there is still no requirement that such trials be registered.
As a result, there is no audit trail that would allow someone to find out the results of a privately financed clinical trial, if the sponsor of that trial did not want the results released.
That is one of the reasons a number of leading medical journals got together and made the decision to require public registration of the trial if the results were eventually going to be published in one of their journals.
This would allow the public to know about the trial, the design of the trial and the planned outcomes of the trial.
And, if someone decided to “bury” a trial, there would be a public record that the results of the trial had not been reported.
So here we are, today, getting a taste of how the results of new medical interventions and innovations are disseminated.
In one example, as noted in my earlier blog, a clinical trial was done and a “teaser” provided to the public (and investors) that this drug was effective as an initial treatment of advanced colorectal cancer. Nothing further was (officially) provided.
In the other example, a company had declined to provide the end points of their trial, and that would have prevented maximum dissemination of the results of the clinical trial in a respected medical journal, but for the “mistake” of another investigator. (In fairness, the editors point out that the particular company in question has improved its behavior considerably, and since 2006 has registered almost all of its trials, providing complete information.)
Again, there are no simple answers to these dilemmas.
But these examples point out that our ethical responsibility is to be certain that people get accurate information and full disclosure in a timely fashion, and not at the expense of their emotions or their lives.
